Tranexamic Acid Mist for Tonsillar Bleeding

(TEAPOT Trial)

Overseen By Stephanie Perez, MHA

Age: < 18

Sex: Any

Trial Phase: Phase < 1

Sponsor: The University of Texas Health Science Center at San Antonio

Disqualifiers: Bleeding disorders, Pregnancy, Allergies, others

Approved in 5 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 3

Duration: 1 hour

12 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What data supports the effectiveness of the drug Tranexamic Acid for tonsillar bleeding?

Research shows that Tranexamic Acid (TXA) can significantly reduce blood loss after a tonsillectomy, which is a common surgery to remove the tonsils. Studies have found that using TXA can decrease the need for further surgical procedures to stop bleeding, making it an effective option for managing post-tonsillectomy hemorrhage. ^{1 2 3 4 5}

Is tranexamic acid (TXA) safe for use in humans?

Tranexamic acid (TXA) has been used safely in various medical settings, including for controlling bleeding in surgeries and difficult nosebleeds, without major complications reported in studies. ^{2 3 4 6 7}

How is the drug Tranexamic Acid used for tonsillar bleeding different from other treatments?

Tranexamic Acid is unique because it can be administered as a mist (nebulized form) to control tonsillar bleeding, which is different from traditional methods that may require surgery or other medications. This approach helps reduce the need for operations and is effective in managing bleeding after tonsillectomy. ^{1 4 5 8 9}

What is the purpose of this trial?

After a child has their tonsils removed, sometimes they might bleed which can be a problem. There is a special mist medicine called nebulized tranexamic acid (TXA) that might help stop the bleeding without having to touch the sore spot. If this mist works well, it could help kids get better by making sure they don't have to go back for more surgery or need blood from someone else. Not having another surgery is good because it means kids won't have to sleep under medicine again, which can sometimes be risky for their brains and breathing, and they won't feel as scared or hurt.

Research Team

Andrew D Meyer, MD, MS

Principal Investigator

The University of Texas Health Science Center at San Antonio

Eligibility Criteria

This trial is for children who have had their tonsils removed and are experiencing bleeding afterwards. It's important that they haven't had any reactions to tranexamic acid before, and they aren't currently taking medication that affects blood clotting.

Inclusion Criteria

I have had my tonsils removed.

My child is between 2 and 17 years old and had a tonsillectomy.

I am experiencing bleeding after a tonsil removal surgery.

Exclusion Criteria

Intubation prior to enrollment

Previously enrolled patients.

Known pregnancy

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive three consecutive doses of nebulized tranexamic acid (TXA) to manage post-operative tonsillectomy hemorrhage

1 hour

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including pain assessment and recurrence of hemorrhage

7 days

2 visits (in-person)

Long-term Follow-up

Participants are monitored for recurrence of post-tonsillectomy hemorrhage and other outcomes

18 months

Treatment Details

Interventions

• Tranexamic Acid

Trial Overview The study is testing a mist medicine called nebulized tranexamic acid (TXA) against normal saline to see if TXA can stop post-operative bleeding in kids without additional surgery or the need for blood transfusions.

Participant Groups

Group I: Nebulized Tranexamic Acid Experimental Treatment 1 Intervention

Subjects will be adminstered nebulized TXA post-tonsillectomy if they return to the emergency room with hemorrhage after surgery

Group II: Nebulized Saline Placebo Group 1 Intervention

Subjects will be adminstered nebulized saline post-tonsillectomy if they return to the emergency room with hemorrhage after surgery

Tranexamic Acid is already approved in United States, European Union, Canada, Japan for the following indications:

Approved in United States as Tranexamic Acid for:

• Heavy menstrual bleeding
• Prevention of excessive bleeding during surgeries

Approved in European Union as Tranexamic Acid for:

• Heavy menstrual bleeding
• Prevention of excessive bleeding during surgeries
• Hereditary angioedema

Approved in Canada as Tranexamic Acid for:

• Heavy menstrual bleeding
• Prevention of excessive bleeding during surgeries

Approved in Japan as Tranexamic Acid for:

• Heavy menstrual bleeding
• Prevention of excessive bleeding during surgeries

Who Is Running the Clinical Trial?

The University of Texas Health Science Center at San Antonio

Lead Sponsor

Trials

486

Recruited

92,500+

References

1. Ireland pubmed.ncbi.nlm.nih.gov

Post-tonsillectomy hemorrhage control with nebulized tranexamic acid: A retrospective cohort study. [2021]

2. United States pubmed.ncbi.nlm.nih.gov

Efficacy of tranexamic acid (TXA) for post-tonsillectomy hemorrhage. [2022]

3. Germany pubmed.ncbi.nlm.nih.gov

Systematic review and meta-analysis of the use of tranexamic acid in tonsillectomy. [2021]

4. United States pubmed.ncbi.nlm.nih.gov

The efficacy of Tranexamic Acid Administration in Patients Undergoing Tonsillectomy: An Updated Meta-Analysis. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Nebulized Tranexamic Acid in Secondary Post-Tonsillectomy Hemorrhage: Case Series and Review of the Literature. [2021]

6. Germany pubmed.ncbi.nlm.nih.gov

Tranexamic acid and post-tonsillectomy hemorrhage: propensity score and instrumental variable analyses. [2020]

7. United States pubmed.ncbi.nlm.nih.gov

Use of Atomized Intranasal Tranexamic Acid as an Adjunctive Therapy in Difficult-to-Treat Epistaxis. [2022]

8. England pubmed.ncbi.nlm.nih.gov

Tranexamic acid - a useful drug in ENT surgery? [2014]

9. Switzerland pubmed.ncbi.nlm.nih.gov

[Result of an antifibrinolytic treatment using tranexamic acid for the reduction of blood-loss during and after tonsillectomy]. [2013]